FDA Inspection 1147671 — ANX Robotica Corp.
The FDA completed an inspection of ANX Robotica Corp. on August 2, 2021 in Plano, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 2, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Plano, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 14719 | 21 CFR 820.30(h) | Incorrect translation to production specifications |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3149 | 21 CFR 820.180 | Availability |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |